Health TrialsbyHealthPanel

Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

ConditionsIrritable Bowel SyndromeFood Allergy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-99
SponsorCook Children's Health Care System

About this trial

The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low/low levels of Immunoglobulin E (IgE) serological tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.

A negative or very low/low levels of Ig-E food allergy panel or negative skin prick test

Negative celiac disease work up

Disqualifiers

If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.

Pregnant or nursing at the time of CLE.

Known allergy to fluorescein.

Impaired renal function tests.

Trial design

Design model

Single group

Treatments tested in this trial

  • Confocal Laser Endomicroscopy

    Device

    1. The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously. 2. The duodenal mucosa is assessed at a minimum of four sites (20 seconds each 3. The first potential allergen will be sprayed via catheter onto the mucosa. 4. After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with IBSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of subjects with IBS symptoms with evidence of epithelial barrier dysfunction

Time frame
Day 1

Secondary outcomes

1

Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scale Questionnaire

The Pediatric Quality of Life Inventory (PedsQL) Questionnaire is an instrument used to measure quality of life in children and adolescents ages 2-18 that can be used by children to self-report or by parents as a proxy. PedsQL Gastrointestinal Symptoms Scales is a specific module of the PedsQL containing 58 items across 10 gastrointestinal symptom scales. Participants rate problems on a scale of 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale, thus higher scores indicate better GI-specific Health-Related Quality of Life (HRQOL) and hence lower symptoms.

Time frame
Baseline, 1 month, 6 months, 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cook Children's Health Care System

Lead sponsor

University of Nebraska Medical Center and Children's Hospital & Medical Center

Collaborator

Stanford University

Collaborator

Metrodora Institute

Collaborator

Meliora Bio ApS

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: